Actively Recruiting
A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
Led by Aura Biosciences · Updated on 2026-04-15
55
Participants Needed
17
Research Sites
231 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main objectives of this study are to determine the feasibility and safety of Belzupacap Sarotalocan (AU-011, bel-sar) treatment of bladder cancer utilizing focal injections with or without laser application.
CONDITIONS
Official Title
A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years and older with a histopathological diagnosis of non-muscle invasive bladder cancer (NMIBC) of any grade
- For first diagnosis of NMIBC, confirmation by biopsy within 6 months before screening is required
- For recurrent NMIBC, current lesion must appear as NMIBC with histopathologic confirmation within last 24 months
- Participants with low-grade intermediate-risk NMIBC meeting specific criteria such as multifocal low-grade Ta, solitary low-grade Ta larger than 3 cm, or low-grade Ta with prior recurrence within 1 year
- Participants with high-risk NMIBC including Ta high-grade papillary disease or T1 papillary disease with or without carcinoma in situ
- Participants may be BCG-naive or have received prior BCG treatment for high-risk or intermediate-risk NMIBC, excluding BCG-refractory patients
- No evidence of current or prior metastatic urothelial carcinoma
- Adequate bone marrow, kidney, and liver function
You will not qualify if you...
- Presence of any other malignancy requiring active treatment unless approved by the Investigator and Medical Monitor
- Use of investigational drugs or devices within 30 days or 5 half-lives before first visit or concurrent enrollment in another investigational trial
- Active bacterial, fungal, or viral infections; all previous infections must be resolved and no systemic anti-infective agents currently used
- Active autoimmune disease, chronic inflammatory conditions, or conditions requiring systemic immunosuppressants or steroids such as organ transplant or bone marrow transplant
- Chronic active hepatitis B or C infection or HIV infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Arkansas Urology
Little Rock, Arkansas, United States, 72211
Terminated
2
Tower Urology
Los Angeles, California, United States, 90048
Actively Recruiting
3
Saint John's Cancer Institute
Santa Monica, California, United States, 90404
Actively Recruiting
4
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
5
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29272
Actively Recruiting
6
Urology Associates, P.C.
Nashville, Tennessee, United States, 37209
Suspended
7
Urology Clinics of North Texas
Dallas, Texas, United States, 75251
Actively Recruiting
8
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
9
The University of Texas San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
10
Urology San Antonio/USA Clinical Trials
San Antonio, Texas, United States, 78229
Actively Recruiting
11
The Urology Place
San Antonio, Texas, United States, 78240
Actively Recruiting
12
Westmead Private Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
13
Austin Health
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
14
Warringal Private Hospital
Heidelberg, Victoria, Australia
Actively Recruiting
15
Penninsula Private Hospital
Langwarrin, Victoria, Australia, 3910
Not Yet Recruiting
16
The Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Not Yet Recruiting
17
Hollywood Private Hospital
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
Research Team
M
Medical Monitor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
10
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